Abstract

A validated specific stability-indicating RP-HPLC method for pioglitazone hydrochloride

Author(s): T.Thilak kumar, B.M.Rao, A.Jamal Abdul Nasser, A.Nallasivam, K.Balakumaran

A simple and rapid specific stability-indicating high-performance liquid chromatographic (HPLC) method developed for a leading anti diabetic drug substance namely Pioglitazone hydrochloride. The developedmethod is very much compatible with LC-MS and shows the superior resolution between the Pioglitazone, its process related impurities and as well the degradation products generated from the forced degradation studies includes hydrolysis, oxidative, photolytic and thermal degradation. The method was developed using Zorbax bonus RP column with water/acetonitrile/ trifluoroacetic acid as amobile phase using a simple linear gradient. The detection was carried out at 225 nm. The method was validated with respect to linearity, precision, accuracy, specificity and robustness. The limit of detection and the limit of quantification for the Pioglitazone and its process related impurities were established. The developed method was found to be suitable to check the quality of bulk samples of Pioglitazone at the time of batch release and also during its storage.